Originally published in The Nano Newswire
Alongside the Food and Drug Administration (FDA), other federal agencies have also waded into the nanotechnology regulatory waters. This Commentary will specifically focus on the efforts of the Environmental Protection Agency.
The Environmental Protection Agency (EPA) protects human health and the environment under numerous statutes. Of interest, the Toxic Substances Control Act (TSCA) maintains an inventory of chemicals, and regulates "new chemicals." The question at issue is whether nanoparticles are "new chemicals" under the TSCA.
In 2005, the EPA hosted public meetings "on the feasibility of establishing a voluntary pilot program for existing nanoscale materials under [] TSCA." To coordinate this voluntary effort, the EPA convened the National Pollution Prevention and Toxics Advisory Committee Interim Ad Hoc Work Group on Nanoscale Materials and in February 2007 the EPA proposed a voluntary framework for manufacturers of nanomaterials under the TSCA in a Nanotechnogy White Paper. The White Paper discusses the potential benefits of nanotechnology and simultaneously addresses the challenges in understanding risks assessment of nanomaterials.
Thereafter in January 2008, the EPA launched the Nanoscale Material Stewardship Program (NMSP), seeking voluntary submissions from manufacturers making or using nanoscale materials in their products. "The program was designed to help the Agency gather existing data and information from manufacturers, importers, processors, and users of nanoscale materials; to build EPA's knowledge base in this area; and to identify and encourage use of risk management practices in developing and commercializing nanoscale materials. EPA decided to initiate the NMSP to quickly learn about commercially available nanoscale materials, while identifying and encouraging risk management practices." 29 companies reported data on 123 nanomaterials to the EPA through the NMSP.
While gathering information to determine the extent that nanomaterials are used, the EPA simultaneously addressed whether nanomaterials constituted "new" chemicals under the TSCA. In 2008, the EPA released a position statement, the "TSCA Inventory Status of Nanoscale Substances – General Approach" that adopts a case-by-case approach in determining the Inventory status of chemical substances. The paper informed the general public that the EPA would only require new applications for nanoscale products when the chemical did not have the same molecular identity as a chemical previously listed. As such, the EPA would not consider properties such as size, shape, and reactivity.
After two years that continued to rely on voluntary efforts, the EPA took its next step in September 2010 and introduced Significant New Use Rules (SNUR) for single and multi-walled carbon nanotubes (CNTs) that are used in a variety of applications. Most recently in May 2011, the EPA issued final SNURs that will require "persons who intend to manufacture, import, or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity." As stated, "EPA believes that this action is necessary because the chemical substance may be hazardous to human health. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs." The Rule became effective June 6, 2011.
The EPA is also pursuing regulation of nanoscale materials in pesticide products under the Federal Insecticide Fungicide, and Rodenticide Act (FIFRA). These efforts are in the beginning stages as the EPA determines a best practice for gathering information as to whether a registered pesticide involves a nanoscale material.
While the FDA and EPA have drawn criticism for their slow
approach towards nanotechnology, their approach reflects an
understanding that nanotechnology is complex and deserving of a
thoughtful regulatory framework. Both agencies have created task
forces, hosted public meetings and invited comments, and have
issued guidance on the agencies' viewpoint on the regulation of
nanotechnology. But only the EPA has taken formal regulatory
action.
As the nanotechnology industry continues to grow and research
efforts are better funded, federal agencies will have firm footing
to step in and fill the regulatory void
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